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Calcitriol Oral Solution

Matched
Active ingredients (original)
CALCITRIOL
Dosage form (original)
SOLUTION
Route (original)
ORAL

Read these limits

  1. US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
  2. The Orange Book lists holder-submitted patents and does not cover all related patents.
  3. “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
  4. This page contains no sales or market-size data and cannot establish development value.
  5. Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.

US-approved products

Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.

Earliest approval1998/11/20
ANDA applications3
RLD applicantESJAY PHARMA LLC

Currently marketed products: 4 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.

Application / product numberBrand name (original)Applicant (original)Dosage form (original)Route (original)Strength (original)Earliest approvalRLD / RSMarketing status (original)Official source
A076242-001CALCITRIOLHIKMA PHARMACEUTICALS USA INCSOLUTIONORALCALCITRIOL: 1MCG/ML2003/07/18N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A203973-001CALCITRIOLANDA REPOSITORY LLCSOLUTIONORALCALCITRIOL: 1MCG/ML2023/07/28N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
A209798-001CALCITRIOLRISING PHARMA HOLDINGS INCSOLUTIONORALCALCITRIOL: 1MCG/ML2018/11/21N / NHUMAN PRESCRIPTION DRUGopenFDA ↗
N021068-001ROCALTROLESJAY PHARMA LLCSOLUTIONORALCALCITRIOL: 1MCG/ML1998/11/20Y / YHUMAN PRESCRIPTION DRUGopenFDA ↗

Listed US patents

*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.

Latest listed patent expiration—
Substance patent expiration (DS flag)—

This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.

Application / product numberPatent numberListed expirationSubstance / product flagsUse codeDelisting requestOfficial source
Not listed

Exclusivity source records

FDA exclusivity code list ↗

Latest exclusivity expiration: —

Application / product numberExclusivity codeListed expirationOfficial source
Not listed

Chinese record details

Chinese product landscape ↗

The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.

Catalog holders 0

Company (original)Identifier (original)Source dateOfficial source
No matching records in this loaded source.

NHSA approval numbers 3

Company (original)Identifier (original)Source dateOfficial source
Hainan Si Da Pharmaceutical Co., Ltd. romanized国药准字H2026355015ml:15μg—Official source ↗
Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized国药准字H2023371515ml:15μg—Official source ↗
Xinjiang Te Feng Pharma Co., Ltd. romanized国药准字H2023373910ml:10μg—Official source ↗

Under review 4

Company (original)Identifier (original)Source dateOfficial source
Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanizedCYHS25039422025/11/13Official source ↗
Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanizedCYHS26024312026/09/29Official source ↗
Shanxi Hui Da Lin Xi Pharmaceuticals Technology Co., Ltd. romanized; Lin Fen Bao Zhu Pharmaceutical Co., Ltd. romanizedCYHS26005232026/02/25Official source ↗
Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanizedCYHS26027192026/11/05Official source ↗

Generic-filing companies this year 3

Company (original)Identifier (original)Source dateOfficial source
Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanizedCYHS26024312026/09/29Official source ↗
Shanxi Hui Da Lin Xi Pharmaceuticals Technology Co., Ltd. romanized; Lin Fen Bao Zhu Pharmaceutical Co., Ltd. romanizedCYHS26005232026/02/25Official source ↗
Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanizedCYHS26027192026/11/05Official source ↗

API companies with A status 10

Company (original)Identifier (original)Source dateOfficial source
Gansu Hao Tian Pharmaceuticals Technology Co., Ltd. romanizedY202300005872024/12/13Official source ↗
MicroBiopharm Japan Co.,Ltd.Y202200002932025/09/23Official source ↗
Nanjing Hai Jing Pharma Co., Ltd., Nanjing Hai Jing Pharma Co., Ltd. romanizedY202200008332026/06/02Official source ↗
Cerbios-Pharma SAY202000012172023/05/08Official source ↗
Nanjing Hai Rong Pharmaceutical Co., Ltd. romanizedY202100000282025/04/04Official source ↗
Sichuan Gowell Pharmaceutical Co., Ltd.Y202000009752026/04/01Official source ↗
Formosa Laboratories, Inc.Y201900214312026/05/20Official source ↗
Qingdao Guo Xin Pharmaceutical Co., Ltd. romanizedY201900094072025/01/15Official source ↗
MicroBiopharm Japan Co.,Ltd.Y20190008975—Official source ↗
Carbogen Amcis B.V.Y201800009892026/10/11Official source ↗
Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanizedY201700012842023/05/11Official source ↗

Trial registrations 2025/2026 —

Not loaded

Sources and dates

FDA Orange Book
2026/11/06
CDE acceptance and review
2026/11/13 06:42
Chemical Drug Catalog
2026/11/13 06:39
API registration records
2026/11/13 06:41
NHSA drug code database
2026/10/23
Trial registry
2026/11/13 08:09 · Incomplete coverage

Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.

Formulation crosswalk to SOLUTION / ORAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-028. Chinese Pharmacopoeia general chapter 0123

Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗

Name and dosage-form matching sources